Advanced Impella SmartAssist System for Subject Monitoring and Treatment: An Early Feasibility Study
||Male and Female Patients
|U.S. Govt. ID:
||Kate Dalton: 347-514-3366 / email@example.com
The purpose of this research study is to evaluate if it is safe and feasible to use the Impella Hemodynamic Platform to measure and display hemodynamic parameters (measurements of how much pressure the heart is generating and how much blood your heart is pumping) during PCI procedures. PCI is a surgical procedure that uses a catheter (a thin flexible tube) to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. The Impella device will be placed via the a femoral artery and delivers up to 3.5 liters of blood per minute to the heart. During its placement, the Impella CP with SmartAssist is positioned in such a way that will allow for the required measurements.
Jeffrey Moses, MD
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